MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD HYPOINT¿ HYPODERMIC NEEDLE

Catalog Number	300255
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7016294.Medical device expiration date: 2022-01-31.Device manufacture date: 2017-02-23.Medical device lot #: 7016296.Medical device expiration date: 2022-01-31.Device manufacture date: 2017-02-23.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported with the use of the bd hypoint¿ hypodermic needle there was an issue with foreign matter.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: from the photos provided, two fm was observed.From the returned samples, the bigger fm was observed as it was placed on the glass plate.However, we could not observe the smaller fm shown in photo 4.The fm placed on the glass plate was sent for ftir and observed to be polypropylene.A review of the device history record revealed no irregularities during the manufacture of the reported lot #.Investigation conclusion: from the returned sample, the fm was observed to be polypropylene.Upon investigation, at the shield removal station, there may be rubbing at the hub with the shield removal plate which contributes to the probable cause of fm.The fm may have stick to the cannula.The shield removal plate was mill down which help to raise the position of the shield removal plate and have more gap between the hub to reduce rubbing.This action has been completed on (b)(6) 2018.The production batch was produced on feb-2017 which is prior to the implementation of the corrective action.
Event or Problem Description
It was reported with the use of the bd hypoint¿ hypodermic needle there was an issue with foreign matter.There was no report of injury or medical intervention.

• Brand Name: BD HYPOINT¿ HYPODERMIC NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8065769
• Report Number: 8041187-2018-00414
• Device Sequence Number: 2190069
• Product Code: FMI
• UDI-Device Identifier: 00382903002559
• UDI-Public: 00382903002559
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 300255
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other